DossierTrans

Italy Dossier & Technical Document Translation Services

Accurate. EU-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Italy-specific and EU-aligned dossiers and technical documents, fully compliant with Italian regulatory authorities and European Union legislation.

We support Italian pharmaceutical manufacturers, Marketing Authorisation Holders (MAHs), importers, distributors, CROs, regulatory consultants, and global companies targeting the Italian and wider EU market with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance in Italy.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Italian and EU market, focused exclusively on scientific, pharmaceutical, biotechnology, medical device, food, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and native-language technical reviewers—not general translators.

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with AIFA / EMA / EU regulatory expectations

Italy Regulatory Alignment

Our services are fully aligned with the requirements of:

• Italian Medicines Agency (AIFA – Agenzia Italiana del Farmaco)
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA)
• European Commission – DG SANTE
• EU Clinical Trials Regulation (CTR 536/2014)
• CTIS / EudraCT systems
• Italian Ministry of Health
• EU Customs & Market Surveillance Authorities

Our Core Services – Italy

📘 Dossier & Technical Document Translation

• Italy- and EU-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for National, MRP, DCP & Centralised procedures
• SmPC, PIL, labeling & artwork text (EU-compliant)
• Italian-language patient leaflets & labeling (mandatory)
• Clinical trial documentation (protocols, IBs, ICFs)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Import, manufacturing authorization & GDP/GMP documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & EU compliance gaps
• Alignment with AIFA guidance, EMA guidelines, EU GMP/GDP, ICH & Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Italy

• AIFA / EMA questions & deficiency letters related to translated content
• Scientific clarification and EU-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local MAHs, Italian agents, EU consultants & CROs

Languages We Support (Italy-Focused)

We provide professional, native-level regulatory translations relevant to Italian and EU submissions:

🌍 EU & International Languages

• English
• German
• French
• Spanish
• Portuguese
• Russian

🇮🇹 Mandatory & Regional Language Support

• Italian – mandatory for labeling & PILs

Foreign Language ↔ Italian | Foreign Language ↔ English

All translations are reviewed by native Italian scientific and regulatory experts experienced with EU procedures.

Industries We Serve – Italy

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics & Biosimilars
• Medical Devices & IVDs
• Clinical Trials & CROs
• OTC & Consumer Health Products
• Food Supplements & Nutraceuticals
• Cosmetics & Dermocosmetics
• Chemicals & Specialty Materials

Why Choose DossierTrans for Italy?

✅ EU & Italy-focused regulatory translation (not generic translation)
✅ Expertise in AIFA, EMA, MRP/DCP & Centralised procedures
✅ Native Italian scientific & regulatory reviewers
✅ Consistent terminology aligned with EU legislation & Ph. Eur.
✅ Authority-ready multilingual documentation
✅ End-to-end support including post-approval queries & variations
✅ Strict confidentiality & data security

Global & Italy Regulatory Expertise

Our Italy services support:

• National and EU marketing authorizations
• Clinical trial submissions via CTIS
• Import & manufacturing authorization dossiers
• Export-support translations for EU, LATAM & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence—especially in Italian PILs or labeling—can delay or block a national or EU approval.

That’s why we deliver precision-driven, regulator-acceptable translations, aligned with Italian and EU compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Italy